Guide Wire Kit, 5.5/6.5/7.3 Cannulated Screws GWK 300Recalls & reported problems

Flower Orthopedics Corporation · surgical instrument or accessory for orthopedic bone fixation · Class 1

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 1
Recalls naming it: 1

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00840118110853), received between May 5, 2021 and May 5, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Fracture” (1 report).

1 FDA recall record name this device's identifier.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

Apr 15, 2021Class IITerminated
Cannulated Screwdrivers may break at the driver tip along the shaft, near the handle extending surgery time and additional x-ray to identify the fragments from the breakages
Z-1698-2021 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Most reported problems

Device problems

Fracture1

Patient problems

No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

InjuryMay 5, 2021Fracture; Fracture
THE EVENT INCLUDED A FRACTURED FLOWER SCREWDRIVER. X-RAY WAS USED TO LOCATE AND REMOVE ALL FRAGMENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11776817 ↗

Device details

UDI-DI	`00840118110853`
Brand	Guide Wire Kit, 5.5/6.5/7.3 Cannulated Screws
Model	GWK 300
Company	Flower Orthopedics Corporation
Product code	HXI · Passer, Wire, Orthopedic
Class	Class 1
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Feb 19, 2024

Device type (GMDN): Orthopaedic bone wire

A wire intended for the fixation of bone fractures that may be implanted or used short-term (e.g., to hold a plate in the correct position during an intervention). It may be used: 1) as a cerclage wire to aid bone fixation; 2) in a loop or figure-of-eight configuration to reattach, e.g., the tip of the elbow (olecranon), tibial tubercle, or greater trochanter; 3) to augment bone screw/plate fixation; or 4) as a Kirschner wire or K-Wire to stiffen (arthrodese) a toe or finger. It is made of metal [e.g., stainless steel, cobalt-chrome (Co-Cr)], and may be malleable or rigid; some types include a nut designed to be attached to the wire to prevent wire migration. This is a single-use device.

Other Passer, Wire, Orthopedic devices

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1 recall4 reports
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Flower Orthopedics Corporation · Passer, Wire, Orthopedic
2 reports
Sure-Lok Extended Tab Pedicle Screw System HXI-48-0003
Precision Spine, Inc. · Passer, Wire, Orthopedic
1 report

All Passer, Wire, Orthopedic devices →

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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